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Sponsored by: |
Indiana University |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00593554 |
The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplasia Chronic Myeloid Leukemia |
Radiation: Total Body Irradiation Drug: Thiotepa Drug: Fludarabine Biological: Rabbit ATG Drug: Palifermin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies |
Estimated Enrollment: | 46 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
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Radiation: Total Body Irradiation
8 Gy on Day -9
Drug: Thiotepa
5 mg/kg/d on Day -8 to -7
Drug: Fludarabine
40 mg/m2/d on Day -6 to -3
Biological: Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
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2: Experimental
Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
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Radiation: Total Body Irradiation
8 Gy on Day -9
Drug: Thiotepa
5 mg/kg/d on Day -8 to -7
Drug: Fludarabine
40 mg/m2/d on Day -6 to -3
Biological: Rabbit ATG
2.5 mg/kg/d on Day -5 to -2
Drug: Palifermin
60 ug/kg (actual body weight) on Day -9 to -7 and Day 0 to +2
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria
Acute lymphoblastic leukemia (ALL) with one of the following criteria
Exclusion Criteria:
Contact: Lisa Wood, RN | 317-274-1781 | llwood@iupui.edu |
Contact: Sherif Farag, MD | 317-274-0843 | ssfarag@iupui.edu |
United States, Indiana | |
Indiana University Cancer Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Lisa Wood, RN 317-274-1781 llwood@iupui.edu | |
Contact: Sherif Farag, MD, PhD 317-274-0843 ssfarag@iupui.edu |
Principal Investigator: | Sherif Farag, MD/PhD | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Sherif Farag, MD, PhD/ Principal Investigator ) |
Study ID Numbers: | 0704-19 IUCRO-0184 |
Study First Received: | January 4, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00593554 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Leukemia, Lymphoid Immunologic Factors Hematologic Neoplasms Precancerous Conditions Leukemia, Myeloid, Acute Leukemia Preleukemia Acute Myelocytic Leukemia Mitogens Lymphoma Acute Lymphoblastic Leukemia Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases |
Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Fludarabine monophosphate Immunosuppressive Agents Thiotepa Antilymphocyte Serum Lymphatic Diseases Leukemia, Myelogenous, Chronic, BCR-ABL Positive Chronic Myelogenous Leukemia Fludarabine Lymphoproliferative Disorders Bone Marrow Diseases |
Leukemia, Lymphoid Hematologic Neoplasms Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Preleukemia Neoplasms by Site Therapeutic Uses Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum Lymphatic Diseases Neoplasms Leukemia, Myelogenous, Chronic, BCR-ABL Positive Fludarabine Lymphoproliferative Disorders Bone Marrow Diseases |